MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX; CLIP, IMPLANTABLE

Model Number CA500

Device Problem Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2022

Event Type  malfunction  

Manufacturer Narrative

The event unit has returned to applied medical for evaluation.A follow-up report will be submitted upon completion of the investigation.

Event Description

Procedure performed: lap.Cholecystektomie.Event description: after insertion of the clipper and first preloading in the abdomen, the clip fell into the abdomen.The next clip was loaded and the same thing happened, also with the third.The clips did not fix themselves in the branches.A cff03 trocar was used.The clips were all recovered.A new clipper was opened.There were no problems here.Whether it was the same lot number could not be found out.The ca500 originates from kit gk738 lot 1438803.Additional information received from complaint evaluation engineer via email on 19apr22: a clip was found to scissor during the [test method] for complaint (b)(4) on 15apr22.Intervention: the clips were all recovered.A new clipper was opened.Patient status: no patient injury.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection of the returned unit observed that the channel support assembly (csa) and feeder, metal components in the shaft, were damaged.The jaws were also observed to be misaligned.Testing was performed on the returned unit, confirming the complainant¿s experience of improper clip loading and clip spitting.During functional testing, the clips fired were either improperly closed or scissored.Based on the condition of the returned unit, it is likely that the reported event was caused by the damaged csa and feeder, which likely resulted from the components being caught within the jaws and further damaged when the device was inserted through the trocar.The clip scissoring was likely caused by the misaligned jaw, however, the exact root cause of the misaligned jaw cannot be determined.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Procedure performed: lap.Cholecystektomie.Event description: after insertion of the clipper and first preloading in the abdomen, the clip fell into the abdomen.The next clip was loaded and the same thing happened, also with the third.The clips did not fix themselves in the branches.A cff03 trocar was used.The clips were all recovered.A new clipper was opened.There were no problems here.Whether it was the same lot number could not be found out.The ca500 originates from kit gk738 lot 1438803.Additional information received from complaint evaluation engineer via email on 19apr22: a clip was found to scissor during the [test method] for complaint (b)(4) on (b)(6) 2022.Intervention: the clips were all recovered.A new clipper was opened.Patient status: no patient injury.

• Brand Name: CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 14197518
• MDR Text Key: 290557479
• Report Number: 2027111-2022-00576
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)240718(30)01(10)1423514
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CA500
• Device Catalogue Number: 101474072
• Device Lot Number: 1423514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/15/2022
• Initial Date FDA Received: 04/25/2022
• Supplement Dates Manufacturer Received: 04/15/2022
• Supplement Dates FDA Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1